Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00036556
Collaborator
(none)
941
234
4
Study Details
Study Description
Brief Summary
This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
941 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
Study Start Date
:
Jun 1, 2001
Outcome Measures
Primary Outcome Measures
- Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer. [Every 12 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have been diagnosed with prostate cancer.
-
Have a rising PSA while on hormone therapy or following surgical castration.
Exclusion Criteria:
-
Have evidence of distant metastatic disease on screening bone scan or CT scan.
-
Have received cytotoxic chemotherapy.
-
Have received opioid or narcotic medications (such as codeine or morphine) or radiation for pain caused by your prostate cancer in the last 6 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Urology Centers Of Alabama | Homewood, | Alabama | United States | 35205 |
| 2 | Alaska Clinical Research Center, LLC | Anchorage | Alaska | United States | 99508 |
| 3 | Advanced Clinical Trials | Tucson | Arizona | United States | 85712 |
| 4 | Arkansas Urologial Associates, PA | Little Rock | Arkansas | United States | 72205 |
| 5 | Robin V. Smith, MD | Chula Vista | California | United States | 91910 |
| 6 | Urology Associate Of Central California | Fresno, | California | United States | 93720 |
| 7 | South Valley Medical Plaza | Gilroy | California | United States | 95020-3535 |
| 8 | San Diego Urology Center | La Mesa | California | United States | 91942 |
| 9 | South Orange County Medical Research Center | Laguna Hills | California | United States | 92653 |
| 10 | UCLA School of Medicine | Los Angeles | California | United States | 90095-1738 |
| 11 | VA Palo Alto | Palo Alto | California | United States | 94304 |
| 12 | Hillcrest Urological Medical Group, Inc. | San Diego | California | United States | 92103 |
| 13 | Urology Associates Of San Luis Obispo | San Luis Obispo, | California | United States | 93405 |
| 14 | Pacific Clinical Research | Santa Monica | California | United States | 90404 |
| 15 | Western Clinical Research, Inc. | Torrance, | California | United States | 90505-4763 |
| 16 | Urology Associate, Pc | Denver, | Colorado | United States | 80210 |
| 17 | South Fl Medical Research | Aventura | Florida | United States | 33180 |
| 18 | Clinical Physiology Associates | Fort Myers | Florida | United States | 33916 |
| 19 | Advanced Research Institute | New Port Richey | Florida | United States | 34652 |
| 20 | Dattoli Cancer Center | Sarasota, | Florida | United States | 34237 |
| 21 | Urology Treatment Center | Sarasota, | Florida | United States | 34239 |
| 22 | Southeastern Urological Center, P.A. | Tallahassee | Florida | United States | 32308 |
| 23 | Peachtree Hematology/Oncology Consultants | Atlanta | Georgia | United States | 30309 |
| 24 | Emory Clinic | Atlanta | Georgia | United States | 30322 |
| 25 | Sandy Springs Urology | Atlanta | Georgia | United States | 30328 |
| 26 | Atlanta Va Medical Center | Decatur | Georgia | United States | 30033 |
| 27 | Dreyer Medical Clinic | Aurora | Illinois | United States | 60506 |
| 28 | Weiss Memorial Hospital | Chicago, | Illinois | United States | 60640 |
| 29 | Northwestern University Medical School | Chicago | Illinois | United States | 60611-3010 |
| 30 | Progressive Care, S.C. | Chicago | Illinois | United States | 60631 |
| 31 | Christopher Ryan, MD | Chicago | Illinois | United States | 60637-1470 |
| 32 | Evanston Hospital Kellogg Cancer Center | Evanston | Illinois | United States | 60201 |
| 33 | Welborn Clinic | Evansville | Indiana | United States | 47713 |
| 34 | Welborn Clinic -East | Evansville | Indiana | United States | 47714-0981 |
| 35 | Urologic Associates, Pc | Davenport | Iowa | United States | 52807 |
| 36 | Iowa Urology | Des Moines | Iowa | United States | 50309 |
| 37 | Kansas University Medical Center | Kansas City, | Kansas | United States | 66160-7390 |
| 38 | Regional Urology | Shreveport | Louisiana | United States | 71106 |
| 39 | LSUHSC | Shreveport | Louisiana | United States | 71130 |
| 40 | Johns Hopkins Oncology Center | Baltimore | Maryland | United States | 21231-1000 |
| 41 | Drs. Werner, Murdock, & Francis, Pa Urology Assoc. | Greenbelt | Maryland | United States | 20770 |
| 42 | Mid Atlantic Clinical Research | Rockville | Maryland | United States | 20850 |
| 43 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114-2617 |
| 44 | Michigan Medical Urology | Grand Rapids | Michigan | United States | 49503 |
| 45 | Michigan Institute Of Urology, Pc | St. Clair Shores | Michigan | United States | 48081 |
| 46 | Lakeside Urology, PC | St. Joseph | Michigan | United States | 49085 |
| 47 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 48 | The Medical Oncology Group | Gulfport, | Mississippi | United States | 39501 |
| 49 | Mississippi Center For Clinical Research, LLC | Jackson | Mississippi | United States | 39216 |
| 50 | St. Joseph Oncology | St. Joseph | Missouri | United States | 64507 |
| 51 | Washington University | St. Louis | Missouri | United States | 63110 |
| 52 | Billings Oncology Associates | Billings, | Montana | United States | 59101 |
| 53 | University of Nebraska Medical Center | Omaha, | Nebraska | United States | 68198-7860 |
| 54 | Nevada Urology Associate | Reno | Nevada | United States | 89509 |
| 55 | UNM Medical Center | Albuquerque | New Mexico | United States | 87131 |
| 56 | Albany Medical Center South Clinical Campus | Albany | New York | United States | 12208-3499 |
| 57 | HemOnCare, PC | Brooklyn | New York | United States | 11235 |
| 58 | Beth Israel Medical Center | New York | New York | United States | 10003 |
| 59 | NYU Medical Center | New York | New York | United States | 10016 |
| 60 | Nyack Hospital | Nyack | New York | United States | 10960 |
| 61 | The University Of North Carolina At Chapel Hill | Chapel Hill | North Carolina | United States | 27599-7235 |
| 62 | Mckay Urology | Charlotte, | North Carolina | United States | 28204 |
| 63 | Urology Specialists Of The Carolinas | Charlotte, | North Carolina | United States | 28207 |
| 64 | Blumenthal Cancer Center | Charlotte | North Carolina | United States | 28203 |
| 65 | The Urology Center | Greensboro, | North Carolina | United States | 27401 |
| 66 | University Of Cincinnati Medical Center | Cincinnati, | Ohio | United States | 45267-0589 |
| 67 | Urologic Specialists Of Oklahoma, Inc. | Tulsa, | Oklahoma | United States | 74104-5433 |
| 68 | Oregon Urology Specialists | Eugene | Oregon | United States | 97401 |
| 69 | Urologic Associates of Allentown | Allentown | Pennsylvania | United States | 18103 |
| 70 | Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 71 | Urological Associates Of Lancaster | Lancaster | Pennsylvania | United States | 17604-3200 |
| 72 | Albert Einstein Medical Center | Philadelphia | Pennsylvania | United States | 19141 |
| 73 | University Of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15232 |
| 74 | Center for Urologic Care | West Reading, | Pennsylvania | United States | 19611 |
| 75 | Multimed Research | Providence, | Rhode Island | United States | 02905 |
| 76 | University of TN - Memphis | Memphis | Tennessee | United States | 38104 |
| 77 | Vanderbilt University Medical Center | Nashville, | Tennessee | United States | 37232-2765 |
| 78 | Urology Associates | Nashville | Tennessee | United States | 37209 |
| 79 | Dept of Veteran's Affairs North Texas Healthcare System | Dallas | Texas | United States | 75216 |
| 80 | Ntouch Research Corporation | Dallas | Texas | United States | 75230 |
| 81 | The University Of TX SW Medical Center At Dallas | Dallas | Texas | United States | 75390-9110 |
| 82 | Uthscsa | San Antonio | Texas | United States | 78229 |
| 83 | Scott & White Memorial Hospital | Temple, | Texas | United States | 76508 |
| 84 | Anthony Middleton, M.D. | Salt Lake City, | Utah | United States | 84102 |
| 85 | Western Urological Clinic | Salt Lake City | Utah | United States | 84107 |
| 86 | University Of Vermont | Burlington, | Vermont | United States | 05403 |
| 87 | Virginia Urology Center | Richmond, | Virginia | United States | 23230 |
| 88 | Jeffrey Frankel, M.D. | Seattle, | Washington | United States | 98166-3059 |
| 89 | Seattle Urological Associates | Seattle | Washington | United States | 98104 |
| 90 | University Of Washington School Of Medicine | Seattle | Washington | United States | 98109-1023 |
| 91 | Madigan Army Medical Center | Tacoma, | Washington | United States | 98431 |
| 92 | Midwest Research Specialists, LLC | Milwaukee | Wisconsin | United States | 53209 |
| 93 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 94 | Wyoming Research Foundation | Cheyenne | Wyoming | United States | 82001 |
| 95 | Prince Of Wales Hospital | Randwick | New South Wales | Australia | 2031 |
| 96 | Westmead Public Hospital | Westmead | New South Wales | Australia | 2145 |
| 97 | Royal Brisbane Hospital | Herston | Queensland | Australia | 4029 |
| 98 | Repatriation General Hospital | Daws Park | South Australia | Australia | 5041 |
| 99 | Peter Maccallum Cancer Institute | East Melbourne | Victoria | Australia | 3002 |
| 100 | Bayside Urology | Mentone | Victoria | Australia | 3194 |
| 101 | Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
| 102 | Princess Alexandra Hospital | Woolloongabba | Australia | QLD 4102 | |
| 103 | A. Ö. Krankenhaus Mistelbach | Mistelbach | Austria | 2130 | |
| 104 | Klinik fur Urologie der Universitat Wien | Wien | Austria | A-1090 | |
| 105 | A.Z. Middelheim | Antwerpen | Belgium | 2020 | |
| 106 | A Z St Jan | Brugge | Belgium | 8000 | |
| 107 | University Hospital Erasme | Bruxelles | Belgium | 1070 | |
| 108 | Uz Gent | Gent | Belgium | 9000 | |
| 109 | Private Practice Dr.Vekemans | Hasselt | Belgium | 3500 | |
| 110 | C.H.U. Liege | Liege | Belgium | 4000 | |
| 111 | St-Elisabeth Ziekenhuis | Turnhout | Belgium | 2300 | |
| 112 | Tom Baker Cancer Center | Calgary, | Alberta | Canada | T2N 4N2 |
| 113 | Cross Cancer Institute | Edmonton, | Alberta | Canada | T6G 1Z2 |
| 114 | Wilson Urology | Kelowna | British Columbia | Canada | V1Y 2H4 |
| 115 | Dr. Cal Andreou | Surrey | British Columbia | Canada | V3V 1N1 |
| 116 | Vancouver Hospital & Health Sciences Centre | Vancouver | British Columbia | Canada | V5Z 3J5 |
| 117 | Dr. P. J. Pommerville, Inc. | Victoria | British Columbia | Canada | V8T5G1 |
| 118 | Dr. Gary Steinhoff, Clinical Research | Victoria | British Columbia | Canada | V8V 3N1 |
| 119 | Abbott Clinic | Winnipeg | Manitoba | Canada | R3C 1V8 |
| 120 | Professional Corporation | Fredericton | New Brunswick | Canada | E3B 5B8 |
| 121 | Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 122 | Valley Professional Centre | Kentville | Nova Scotia | Canada | B4N 4K9 |
| 123 | The Male Health Centres | Barrie | Ontario | Canada | L4M 4S5 |
| 124 | The Urology Resource Centre | Burlington | Ontario | Canada | L7S 1V2 |
| 125 | Hamilton & District Urology Association | Hamilton, | Ontario | Canada | L8N 1T8 |
| 126 | Kingston General Hospital | Kingston | Ontario | Canada | K7L 2V7 |
| 127 | Probidity Medical Research | Kitchener | Ontario | Canada | N2M 5N6 |
| 128 | London Health Sciences Centre | London | Ontario | Canada | N6A 4G5 |
| 129 | Quest Clinical Trials | Markham | Ontario | Canada | L6B 1A1 |
| 130 | Walk-In Clinic | North Bay | Ontario | Canada | P1B 4Z2 |
| 131 | Jack Barkin, M.D. | North York | Ontario | Canada | M6A 3B5 |
| 132 | The Male Health Centres | Oakville | Ontario | Canada | L6H 3P1 |
| 133 | Ottawa Hospital Civic Campus | Ottawa | Ontario | Canada | K1Y 4E9 |
| 134 | Advanced Male Fertility Clinic | Scarborough, | Ontario | Canada | M1S 4V5 |
| 135 | Northeastern Ontario Regional Cancer Centre | Sudbury, | Ontario | Canada | P3E 5J1 |
| 136 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 137 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 138 | Service Radio-Oncologie, Chus | Fleurimont, | Quebec | Canada | J1H 5N4 |
| 139 | Hopital Notre-Dame | Montreal | Quebec | Canada | H2L 4M1 |
| 140 | Royal Victoria Hospital | Montreal | Quebec | Canada | H3A 1A1 |
| 141 | Ultramed | Pointe Claire | Quebec | Canada | H9R 4S3 |
| 142 | Peter Lau, MD | Saskatoon, | Saskatchewan | Canada | S7K 3H3 |
| 143 | Chuq Pavillon Hotel-Dieu | Quebec | Canada | G1R 2J6 | |
| 144 | Hôpital Cochin | Paris | Cedex 14 | France | 75679 |
| 145 | Hopital Intercommunal | Creteil | Cedex | France | 94010 |
| 146 | Hôpital Salvator | Marseille | Cedex | France | 9 13274 |
| 147 | Hôpital Pasteur | Nice | Cedex | France | 3 06202 |
| 148 | Hôpital Saint Louis | Paris | Cedex | France | 10 75475 |
| 149 | Centre Hospitalier Rene Dubos | Pontoise | Cedex | France | 95303 |
| 150 | Hopital De Pontchaillou | Rennes | Cedex | France | 35033 |
| 151 | Hopital De Rangueil | Toulouse | Cedex | France | 31043 |
| 152 | Hôpital D´Auxerre | Auxerre | France | 89000 | |
| 153 | Hôpital Henri Mondor | Creteil | France | 94010 | |
| 154 | Hopital Bichat Claude Bernard | Paris | France | 75018 | |
| 155 | Allgemeines Krankenhaus Urologie | Celle | Germany | 29223 | |
| 156 | Universitätsklinikum Urologie | Essen | Germany | 45147 | |
| 157 | Universitätsklinkum | Freiburg | Germany | 79106 | |
| 158 | Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany | 20246 | |
| 159 | Allgemeines Krankenhaus Barmbek | Hamburg | Germany | 22291 | |
| 160 | Klinik Und Poliklinik für Urologie und Kinder | Homburg / Saar | Germany | 66421 | |
| 161 | Universitätsklinikum Lübeck Urologie | Lübeck | Germany | 23538 | |
| 162 | Universitätsklinikum Mannheim | Mannheim | Germany | 68135 | |
| 163 | Urologische Klinik Und Poliklinik Grosshadern | Munchen | Germany | 81377 | |
| 164 | Klinikum Rechts Der Isar | Munchen | Germany | 81675 | |
| 165 | Universitat Ulm | ULM | Germany | 89070 | |
| 166 | Klinikum Wuppertal GmbH | Wuppertal | Germany | 42283 | |
| 167 | 'Alexandra' Hospital | Athens | Greece | 115 27 | |
| 168 | Pe.Pa.G.N.I Hospital | Heraklion | Greece | 711 10 | |
| 169 | G. Genimatas Hospital | Thessaloniki | Greece | 546 35 | |
| 170 | Tallaght Hospital | Dublin | Ireland | 24 | |
| 171 | St Vincent'S Hospital | Dublin | Ireland | 4 | |
| 172 | Mater Misericordiae Hospital | Dublin | Ireland | 7 | |
| 173 | Clinica Urologica I - Università di Bari | Bari | Italy | 70124 | |
| 174 | Istituto Nazionale per la Ricerca sul Cancro -IST | Genoa | Italy | 16132 | |
| 175 | Istituto Europeo di Oncologia | Milan | Italy | 20141 | |
| 176 | Clinica Urologica - Università Di Milano | Milan | Italy | 20142 | |
| 177 | Istituto di Urologia | Padova | Italy | 35128 | |
| 178 | Policlinico G. B. Rossi | Verona | Italy | 37134 | |
| 179 | Amc | Amsterdam | Netherlands | 1105 AZ | |
| 180 | Rijnstate Hospital | Arnhem | Netherlands | 6815 AD | |
| 181 | Medisch Spectrun Twente | Enschede | Netherlands | 7500 KA | |
| 182 | Atrium Heerlen | Heerlen | Netherlands | 6401 CX | |
| 183 | University Hospital Rotterdam | Rotterdam | Netherlands | 3015 GD | |
| 184 | St Franciscus Gasthuis | Rotterdam | Netherlands | 3045 PM | |
| 185 | Canterbury Urology Research Trust | Christchurch | New Zealand | ||
| 186 | Promed Urology Ltd. | Tauranga | New Zealand | ||
| 187 | Samodzielny Publiczny ZOZ | Bydgoszcz | Poland | 85-168 | |
| 188 | Katedra i Klinika Urologii - Akademia Medyczna w Gdansku | Gdansk | Poland | 80-742 | |
| 189 | Specjalistyczny Szpital Urologiczny | Katowice | Poland | 40-073 | |
| 190 | Szpital Kliniczny Dzieciatka Jezus | Warszawa | Poland | 02-034 | |
| 191 | Instytut im. Marii Sklodowskiej-Curie | Warszawa | Poland | 02-781 | |
| 192 | Akademia Medyczna we Wroclawiu | Wroclaw | Poland | 50-043 | |
| 193 | Mediclinic Hospital | Petermaritzburg | 3201 | South Africa | |
| 194 | University Of Stellenbosch | Cape Town | South Africa | ||
| 195 | University Of Natal - Nelson R Mandela School of Medicine | Durban | South Africa | 4013 | |
| 196 | Kenridge St Joseph Wingl | Parktown | South Africa | 2010 | |
| 197 | Medi-Clinic Hospital | Pietermaritzburg | South Africa | 3201 | |
| 198 | Medical Centre | Pietermaritzburg | South Africa | 3201 | |
| 199 | Pretoria Urology Hospital | Pretoria | South Africa | 0083 | |
| 200 | Hospital de la Ribera | Alcira (Valencia) | Spain | 46600 | |
| 201 | Hospital Vall D'Hebron | Barcelona | Spain | 08035 | |
| 202 | Hospital de Galdakao | Galdakao-Vizcaya | Spain | 48960 | |
| 203 | Hospital Juan Canalejo | La Coruna | Spain | 15006 | |
| 204 | Clinica Puerta De Hierro | Madrid | Spain | 28035 | |
| 205 | Hospital 12 De Octubre | Madrid | Spain | 28041 | |
| 206 | Hospital Carlos Haya | Malaga | Spain | 29009 | |
| 207 | Hospital Marques De Valdecilla | Santander | Spain | 39008 | |
| 208 | Instituto Valenciano De Oncologia | Valencia | Spain | 46009 | |
| 209 | Sahlgrenska University Hospital | Gothenburg | Sweden | 41345 | |
| 210 | Linkoping University Hospital | Linkoping | Sweden | 501 85 | |
| 211 | Lund University Hospital | Lund | Sweden | 221 85 | |
| 212 | Malmo University Hospital MAS | Malmo | Sweden | 205 02 | |
| 213 | Karolinska Hospital | Stockholm | Sweden | 171 76 | |
| 214 | Uppsala University Hospital | Uppsala | Sweden | 751 85 | |
| 215 | Royal Devon And Exeter Hospital | Exeter, | Devon | United Kingdom | EX2 5DW |
| 216 | Lister Hospital | Stevenage | Hertfordshire | United Kingdom | SG1 4AB |
| 217 | Northwick Park Hospital | Harrow | Middlesex | United Kingdom | HA1 3UJ |
| 218 | Western General Hospital | Edinburgh, | Scotland | United Kingdom | EH4 2XU |
| 219 | Taunton And Somerset Hospital | Taunton | Somerset | United Kingdom | TA1 5DA |
| 220 | The Institute Of Cancer Research - Royal Marsden Hospital | Sutton | Surrey | United Kingdom | SM2 5PT |
| 221 | St Lukes Hospital | Bradford | West Yorkshire | United Kingdom | BD5 0NA |
| 222 | Clatterbridge Centre For Oncology | Bebington | Wirral | United Kingdom | CH63 4JY |
| 223 | Southmead Hospital | Bristol | United Kingdom | BS10 5NB | |
| 224 | Addenbrookes Hospital | Cambridge | United Kingdom | CB2 2QQ | |
| 225 | St Richard'S Hospital | Chichester | United Kingdom | PO19 4SE | |
| 226 | Leighton Hospital | Crewe | United Kingdom | CW1 4QJ | |
| 227 | Gartnavel General Hospital | Glasgow | United Kingdom | G12 0YN | |
| 228 | Glasgow Royal Infirmary | Glasgow | United Kingdom | G31 2ER | |
| 229 | St Batholomew'S Hospital | London | United Kingdom | EC1A 7BE | |
| 230 | Royal Free Hospital | London | United Kingdom | NW3 2QG | |
| 231 | Clinical Research Centre - St Georges Hospital | London | United Kingdom | SW17 0QT | |
| 232 | Hope Hospital | Salford | United Kingdom | M6 8HD | |
| 233 | Royal Hallamshire Hospital | Sheffield | United Kingdom | S10 2JF | |
| 234 | Southampton General | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Abbott
Investigators
- Study Director: Gary Gordon, M.D., Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00036556
Other Study ID Numbers:
- M00-244
- NCT00026455
First Posted:
May 13, 2002
Last Update Posted:
Aug 15, 2007
Last Verified:
Aug 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: